BAAT Medical
BAAT Medical offers end-to-end solutions for medical device innovation, from strategy and funding to development, manufacturing, and regulatory compliance. They specialize in Class I-III devices, including implants and wearables, ensuring efficient market entry.
BAAT Medical is a comprehensive partner for medical device innovators, providing end-to-end solutions to bring cutting-edge technologies to market. They cater to a range of medical devices, from Class I to Class III, including instruments, wearables, (smart) implants, custom-made products, and medicinal combination devices. Their expertise spans the entire product lifecycle, starting with strategic evaluation of the device idea, market research, and business case development. They assist in securing funding, guiding startups and established companies through the financial landscape. The development phase is handled with a focus on turning concepts into tangible, market-ready products, ensuring innovative design and regulatory compliance. BAAT Medical also excels in manufacturing, scaling production to meet market demands while maintaining quality and readiness for approval. Furthermore, they offer robust regulatory affairs support, including navigating complex regulations like the MDR, and act as the Legal Manufacturer for custom-made devices, ensuring patient safety and compliance. Their proven process minimizes risks and optimizes for successful market entry or exits, helping clients achieve real-world impact in medical device innovation.
About
**Who they are**
BAAT Medical is an end-to-end solutions provider for medical device innovation, specializing in bringing devices from strategy and funding through development, manufacturing, and regulatory compliance to market.
**Expertise & scope**
* End-to-end support for medical device innovation.
* Expertise in strategy, including market research, market entry, business case development, and industry connections.
* Funding support for entrepreneurs, startups, and technology transfer offices, including early-stage funding solutions.
* Development services to bring medical device visions into reality.
* Streamlining manufacturing and product delivery.
* Ensuring ongoing regulatory compliance.
* Specialization in Class I-III devices, including implants and wearables.
* Regulatory compliance services, including acting as the Legal Manufacturer for MDR-compliant custom-made 3D-printed products (Class IIa), providing Statements Annex XIII.
**Reputation / proof points**
* Coverage: EU
* Languages: English, Dutch
BAAT Medical is an end-to-end solutions provider for medical device innovation, specializing in bringing devices from strategy and funding through development, manufacturing, and regulatory compliance to market.
**Expertise & scope**
* End-to-end support for medical device innovation.
* Expertise in strategy, including market research, market entry, business case development, and industry connections.
* Funding support for entrepreneurs, startups, and technology transfer offices, including early-stage funding solutions.
* Development services to bring medical device visions into reality.
* Streamlining manufacturing and product delivery.
* Ensuring ongoing regulatory compliance.
* Specialization in Class I-III devices, including implants and wearables.
* Regulatory compliance services, including acting as the Legal Manufacturer for MDR-compliant custom-made 3D-printed products (Class IIa), providing Statements Annex XIII.
**Reputation / proof points**
* Coverage: EU
* Languages: English, Dutch
Additional information
BAAT Medical offers a comprehensive approach to medical device commercialization. Their regulatory compliance services are particularly noted for addressing the complexities of 3D-printed custom-made devices under the MDR. By acting as the Legal Manufacturer for specific 3D-printed products, they provide a clear compliance route, issuing Statements Annex XIII to confirm MDR compliance. This service is designed for 3D print labs and hospitals ordering such devices, clarifying accountability and ensuring patient safety. They also highlight the importance of looking beyond a Declaration of Conformity to a Statement Annex XIII for MDR compliance.
Key Highlights
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Offers end-to-end solutions for medical device innovation, covering strategy, funding, development, manufacturing, and regulatory compliance.
Source
“From crafting your strategy, developing your product, streamlining manufacturing and delivering your product everywhere while ensuring ongoing compliance.”
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Specializes in Class I-III devices, including implants and wearables.
Source
“They specialize in Class I-III devices, including implants and wearables, ensuring efficient market entry.”
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Acts as the Legal Manufacturer for MDR-compliant custom-made 3D-printed products (Class IIa), providing Statements Annex XIII.
Source
“BAAT Medical acts as the Legal Manufacturer, ensuring full compliance with the Medical Device Regulation (MDR). BAAT validated the process and created a technical file and now issues a Statement Annex XIII with each product, confirming its MDR compliance.”
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Provides comprehensive funding support for entrepreneurs, early-stage startups, and technology transfer offices.
Source
“Turning an innovative medical device into a commercial success starts with the right funding strategy. Whether you’re a single entrepreneur, an early stage startup or a technology transfer office, we provide comprehensive funding support to get you the financial backing you need.”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Medical device innovators seeking end-to-end support.
- Companies needing regulatory strategy and compliance, especially for 3D-printed devices.
- Startups requiring funding and development assistance.
How engagement typically works
- Collaborative, end-to-end partnership.
- Acting as Legal Manufacturer for specific regulatory pathways.
Typical deliverables
- Regulatory strategy and compliance documentation (e.g., Technical Files, Statements Annex XIII).
- Market access and business case development.
- Funding acquisition support.
- Product development and manufacturing streamlining.
Good to know
- Best when seeking comprehensive support from concept to market.
- Most relevant for EU market entry and MDR compliance.
HQ:
Hengelo, Netherlands
Languages:
English, Dutch
Timezones:
Europe/Amsterdam
Claim status:
Listed
Services & Capabilities
PRRC MDR (EU MDR) | PRRC Medical Device Service | Compare Providers & Get Quotes
Jurisdictions:
EU
Countries:
US, EU
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
26-100
Onboarding time:
3–14 days
Pricing model:
Onboarding + annual retainer
Starting from:
EUR 3,200
Included services:
PRRC appointment support, Lifecycle compliance oversight, Change-impact escalation, PMS/vigilance coordination support
Named PRRC:
Yes
Device Classes Supported:
Class I, Class IIa
PRRC Qualification Summary:
BAAT Medical acts as the Legal Manufacturer, ensuring full compliance with the Medical Device Regulation (MDR). BAAT validated the process and created a technical file and now issues a Statement Annex XIII with each product, confirming its MDR compliance. Hospitals retain responsibility for clinical use, but BAAT shoulders the accountability as the Legal Manufacturer, ending the back-and-forth confusion. This MDR-approved route designates BAAT as the responsible party, safeguarding patient safety and ensuring regulatory compliance in healthcare. The question of “Who is the Legal Manufacturer?” is now solved with BAAT Medical as the Legal Manufacturer and 3DMM as the production expert, this partnership delivers MDR-compliant custom-made devices with transparency and trust.
Additional prrc_service Details
Included Services Detailed
Appointment and mandate support for outsourced PRRC coverage (seed scope), Lifecycle compliance oversight aligned to Article 15 activities (seed scope), Change-impact triage and escalation support (seed scope), Periodic compliance reporting to management (seed scope)
Excluded Services
Notified Body decision-making on conformity assessment, Acting as Legal Manufacturer unless separately contracted, Commercial distribution or importer/distributor operations
Onboarding Steps
Implied process involves evaluating value proposition, performing a Business Scan, and developing strategy, funding, development, manufacturing, and compliance plans.
Coverage Details
PRRC availability set to Extended hours with defined escalation path (seed summary).
Device Classes Supported
Class I, IIa, IIb, III
Supports MDR
Yes
Supports IVDR
No
PRRC Qualification Summary
Acts as Legal Manufacturer for MDR compliance, validating processes and creating technical files.
Regulatory Experience
Extensive experience in medical device regulatory compliance, particularly for 3D-printed devices under MDR.
